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Trial registered on ANZCTR


Registration number
ACTRN12619001174178
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
20/08/2019
Date last updated
10/12/2020
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prisma in minor amputations
Scientific title
A randomised trial of perioperative use of combination oxidized regenerated cellulose, collagen and silver (Promogran Prisma™) dressing in lower limb minor amputations.
Secondary ID [1] 298936 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
minor amputation of the lower limb 313925 0
Condition category
Condition code
Surgery 312332 312332 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised control trial designed to test the hypothesis:
1. Promogran Prisma provides improved wound healing in patients who undergo minor amputation of the lower limb.

Promogran Prisma is a matrix topical wound dressing composed of 55% bovine derived collagen, 44% oxidised regenerated cellulose (ORC) and 1% silver ORC.

Patients will be randomised using a pre-randomised secret envelope system containing random assignment to either control or trial group, available at the time of lower limb minor amputation:

A trial group who will receive Promogran Prisma ™ as primary dressing, placed into the wound bed post completion of minor amputation, The Promogran Prisma ™ will be covered with absorbent secondary dressings and secured with crepe bandage. The dressing will be reviewed at the 48 hour mark unless otherwise indicated. The patient will continue to use Promogran Prisma ™ as the primary wound dressing and will remain the only variable to standard minor amputation post-operative wound management for a period of 12 weeks. This group will be used to assess the effect of Promogran Prisma™ as a primary wound dressing for minor amputations.

Dressings will be applied by the governing surgical team intraoperatively, and then by hospital and community nursing staff post initial intraoperative placement. This follows the current usual standard of care.
Intervention code [1] 315211 0
Treatment: Devices
Comparator / control treatment
A control group, who will receive the usual standard care for post-operative minor amputation wound management. The usual standard of care at our institution consists of a calcium alginate dressing and a silicone adhesive dressing placed into the wound bed and covered with absorbent secondary dressings secured with crepe bandage. This dressing will be removed at the 48 hour mark unless otherwise indicated. The patient will then receive ongoing wound management as determined by the vascular surgery unit clinical team, however the patient is not to receive Promogran Prisma ™ as a primary dressing at any point during the 12 week follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 320959 0
Proportion of patients with 100% wound healing defined as: 100% wound bed epithelialisation prior to or by the end of the trial timeframe (12 weeks).
Timepoint [1] 320959 0
12 weeks
Secondary outcome [1] 373521 0
Total number of dressing changes required between control - Total number of dressing changes from day of initial amputation surgery will be recorded via a study specific assessment tool.
Timepoint [1] 373521 0
Total number of dressing changes to be recorded and tallied at end of 12 week period.
Secondary outcome [2] 373517 0
Wound bed tissue quality, to be facilitated through use of the Wound Bed Score – a validated tool to objectively quantify quality of wound bed tissue,
Timepoint [2] 373517 0
Assessment to be performed at 48 +/- 12 hours, 2 weeks (+/- 3 days), 4 weeks(+/- 5 days), 8 weeks (+/- 5 days) and 12 weeks (+/- 5 days) post minor amputation surgery.
Secondary outcome [3] 373515 0
I. Time to complete wound epithelialisation – defined as number of days from date of minor lower limb amputation surgery to date of 100% wound bed epithelialisation.
Timepoint [3] 373515 0
Assessments to be performed at 48 +/- 12 hours, 10 days (+/- 3 days), 4 weeks(+/- 5 days), 8 weeks (+/- 5 days) and 12 weeks (+/- 5 days) post minor amputation surgery post minor amputation.
Secondary outcome [4] 373520 0
Wound Infection rates – wounds will be assessed and scored according to the definitions outlined in the Infectious Diseases Society of America and International Working Group on the Diabetic Foot Classifications of Diabetic Foot Infection – Clinical Manifestations of Infection (a validated tool).
Timepoint [4] 373520 0
Measurements to be taken at 48 +/- 12 hours, 10 days (+/- 3 days), 4 weeks(+/- 5 days), 8 weeks (+/- 5 days) and 12 weeks (+/- 5 days) post minor amputation surgery.
Secondary outcome [5] 373519 0
Pain related to wound dressing change procedures. Pain will be assessed before and after dressing change procedure using a visual pain scale (allows for verbal an non-verbal assessment of pain).
Timepoint [5] 373519 0
Measurements to be taken at 48 +/- 12 hours, 10 days (+/- 3 days), 4 weeks(+/- 5 days), 8 weeks (+/- 5 days) and 12 weeks (+/- 5 days) post minor amputation surgery.
Secondary outcome [6] 373516 0
Rate of wound healing, to be ascertained through absolute (cm2) and relative (%) wound surface area and tissue volume reduction, this will include clinical photography of the wound bed:
Timepoint [6] 373516 0
Measurements to be taken at 48 +/- 12 hours, 10 days (+/- 3 days), 4 weeks(+/- 5 days), 8 weeks (+/- 5 days) and 12 weeks (+/- 5 days) post minor amputation surgery.
Secondary outcome [7] 373522 0
Revascularisation post minor lower limb amputation – defined as any patient requiring either a peripheral angiogram procedure or arterial bypass procedure to facilitate revascularisation of the lower limb on which amputation surgery has occurred. Revascularisation of lower limb arteries of a limb which has undergone minor amputation is an endpoint for patient participation in the study as changes in peripheral perfusion present a confounder to impact of dressing product on tissue regeneration. Data will be linked to medical records, where participant information is flagged to trigger notification of study supervisor in the event of revascularisation procedure.
Timepoint [7] 373522 0
To be assessed at 12 weeks via review of medical records or at time of event.
Secondary outcome [8] 373523 0
Major limb amputation, defined as amputation of at trans-tibial or proximal, of the limb which has undergone minor amputation is an end point for patient participation in the study. Data will be linked to medical records, where participant information is flagged to trigger notification of study supervisor in the event of revascularisation procedure.
Timepoint [8] 373523 0
To be assessed at 12 weeks via review of medical records or at time of event.

Eligibility
Key inclusion criteria
All patients undergoing minor amputation of the foot (single or multiple digits, to base of metatarsal as maximum depth debrided / amputated) at Flinders Medical Centre, where the surgical site has been left open to heal via secondary intention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients who live interstate, rural or remote or who are not able to attend the scheduled appointed review time frames.
ii. Patients under 18 years of age.
iii. Patients who are unable to give informed consent due to language difficulties or physical/mental incapacity.
iv. A minor amputation where the operative wound bed has been closed using primary closure methods (suture, staples).
v. Patients with known hypersensitivity to any components of Promogran Prisma™ - oxidised regenerated cellulose, collagen and silver.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised assignment to control or trial arms of study to be facilitated by random number generation (even number assigned to trial, odd number assigned to control) via opaque envelope prepared by external source.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be facilitated using www.sealedenvelope.com, using the following parameters: Two treatment groups assigned as "Promogran" and "Standard", assigned a black size of 2 and a list length of 56. The list will be generated using the unique randomisation code, thus randomisation will be blinded.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size calculation:

A multicentre RCT comparing use of a protease mitigating dressing16 (Collagen/oxidised regenerated cellulose/silver) versus care using control wound management products in a diabetic foot ulcer cohort demonstrated a 26% percentage point increase (p=0.035) in wound area reduction rates when compared with the control group. This study recruited a total of 39 patients, (24 trial [79% >50% wound surface area reduction]; 14 control [43% wound surface area reduction].
Utilising the results from the above trial as anticipated incidence for the outcomes of our trial a power calculation using clincalc.com has outlined a sample size of 56 patients (28 each arm) to achieve 80% power at 0.05 significance level.
Flinders Medical Centre performed a total of 117 minor amputations in 2017, hence the study enrolment duration has been set as being 12 months, to allow enough time for single centre enrolment of the nominated sample size and to also allow for an approximate 15% drop out rate and 75% eligibility of our minor amputation cases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/08/2019
Actual
16/09/2019
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
56
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14435 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 27446 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 303476 0
Hospital
Name [1] 303476 0
Flinders Medical Centre
Country [1] 303476 0
Australia
Primary sponsor type
Individual
Name
Dr Chris Delaney
Address
Department of Vascular and Endovascular Surgery
c/- L2 Wilson Cark Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Australia
Country
Australia
Secondary sponsor category [1] 303534 0
Individual
Name [1] 303534 0
Mr Frank Guerriero
Address [1] 303534 0
Department of Vascular and Endovascular Surgery
c/- L2 Wilson Cark Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Australia
Country [1] 303534 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304006 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 304006 0
Ethics committee country [1] 304006 0
Australia
Date submitted for ethics approval [1] 304006 0
01/04/2019
Approval date [1] 304006 0
17/07/2019
Ethics approval number [1] 304006 0
82.19

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95534 0
Dr Chris Delaney
Address 95534 0

Department of Vascular and Endovascular Surgery
c/- L2 Wilson Cark Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Australia
Country 95534 0
Australia
Phone 95534 0
+61 08 8204 5445
Fax 95534 0
+61 08 8204 7106
Email 95534 0
Chris.Delaney@sa.gov.au
Contact person for public queries
Name 95535 0
Frank Guerriero
Address 95535 0

Department of Vascular and Endovascular Surgery
c/- L2 Wilson Cark Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Australia
Country 95535 0
Australia
Phone 95535 0
+61 08 8204 5445
Fax 95535 0
+61 08 82047106
Email 95535 0
frank.guerriero@sa.gov.au
Contact person for scientific queries
Name 95536 0
Frank Guerriero
Address 95536 0

Department of Vascular and Endovascular Surgery
c/- L2 Wilson Cark Park Building
Flinders Medical Centre
Flinders Drive
Bedford Park, SA 5042
Australia
Country 95536 0
Australia
Phone 95536 0
+61 08 8204 5445
Fax 95536 0
+61 08 82047106
Email 95536 0
frank.guerriero@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only, and only after being de-identified.
When will data be available (start and end dates)?
Start date of data availability estimated: 1st December 2020. No end date determined.
Available to whom?
Data will be provided on a case by case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Meta-analysis, any research with purpose aligned with the study objectives detailed in the proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator via email - Chris.Delaney@sa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3788Study protocol  frank.guerriero@sa.gov.au 378119-(Uploaded-05-08-2019-14-57-07)-Study-related document.docx
3789Informed consent form  frank.guerriero@sa.gov.au 378119-(Uploaded-27-07-2020-12-24-15)-Study-related document.doc
3790Ethical approval  frank.guerriero@sa.gov.au 378119-(Uploaded-05-08-2019-15-01-06)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.